The safety of recombinant factor VIIa in cardiac surgery.

Abstract

We investigated whether there was an association between recombinant activated factor VII (rFVIIa) use in cardiac surgery and thromboembolic events by comparing cases in two medical registries. The incidence of thromboembolic events in patients undergoing cardiac surgery (except isolated coronary artery bypass grafts) who had received rFVIIa and were entered into the Australian and New Zealand Haemostasis Registry was compared with the background incidence in patients entered in the Australasian Society for Cardiac and Thoracic Surgeons database. Mortality, length of hospital stay and thromboembolic complications such as stroke, perioperative myocardial infarction and pulmonary embolism data were analysed. A total of 705 patients in the Registry were compared with 6554 patients in the Thoracic Surgeons database. The use of rFVIIa was independently associated with higher mortality (odds ratio 2.55, P < 0.001) and longer hospital stay (odds ratio 1.54, P = 0.020). However multiple regression analyses showed no independent association between rFVIIa and stroke (odds ratio 1.0, P = 0.994) or perioperative myocardial infarction (odds ratio 0.29, P = 0.053), while the use of rFVIIa was associated with fewer pulmonary emboli (odds ratio 0.02, P < 0.001). These findings indicate that patients who received rFVIIa had increased mortality and length of hospital stay, as expected, but that rFVIIa use was not associated with an increased incidence of stroke or perioperative myocardial infarction. In the absence of randomised controlled clinical trials, this analysis suggests that the off-label use of rFVIIa in cardiac surgery does not significantly increase thromboembolic events.